Senior External Clinical Supply Quality Analyst

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Sur place; EUR 73 000 - 115 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Résumé du poste

Johnson & Johnson seeks a Sr Analyst, External Clinical Supply Quality to oversee QA for external manufacturers involved in packaging, labeling, and distribution of Investigational Medicinal products. The role supports continuous improvement and regulatory compliance across multiple sites.

The individual will ensure cGMP compliance, manage supplier quality agreements, and drive risk-based approaches to resolve quality issues while collaborating with internal stakeholders globally.

Qualifications

• Bachelor's degree in Science, Engineering or technical subjects.
• 6+ years in Pharmaceuticals or regulated environment.
• 4+ years in Quality/Compliance preferred.
• Excellent communication and analytical skills.
• Ability to lead audits of external suppliers.

Responsabilités

• Serve as QA contact for External Manufacturer/Supplier for J&J product.
• Signatory authority for QA in projects.
• Lead qualification during supplier selection and audits.
• Negotiate and approve Quality Agreements with suppliers.
• Support quality systems and CAPAs at external suppliers.
• Provide GMP compliance support and risk-based quality management.
• Lead phase-appropriate GMP at packaging/label suppliers.
• Build relationships with suppliers to drive compliance and improvement.
• Review regulatory documents prior to submissions.

Connaissances

Communication skills

English (fluent)

Analytical skills

Independence

cGMP knowledge

Audits experience

Formation

Bachelor's degree in Science/Engineering/Technical fields

Outils

TruVault

COMET

MS Office

Description du poste

Johnson & Johnson seeks a Sr Analyst, External Clinical Supply Quality to oversee QA for external manufacturers involved in packaging, labeling, and distribution of Investigational Medicinal products. The role supports continuous improvement and regulatory compliance across multiple sites.

The individual will ensure cGMP compliance, manage supplier quality agreements, and drive risk-based approaches to resolve quality issues while collaborating with internal stakeholders globally.